Even when the mega-billion drug companies admit to federal wrongdoings,
they often get away a light slap on the wrist and, if they're lucky,
can still make an obscene amount of money on the open market besides.
A great example is Warner-Lambert, a one-time independent now owned
by Pfizer that recently pled guilty to illegally marketing Neurontin
for treating ailments it wasn't approved to cover before August
1996. Warner-Lambert paid a sizeable fine ($430 million) and its
parent agreed to stricter rules to compliance laws tighter than
existing marketing rules. In addition, it also agreed to fund a
multi-million program to educate doctors about Neurontin.
Think the publicity made Neurontin a pariah? Guess again. For one,
the Warner-Lambert executives who executed the marketing plan were
never prosecuted for their shenanigans. Lastly, and most importantly,
Neurontin sales in 2004 are projected to exceed last year's totals:
$2.7 billion. Federal law prohibits drug firms from marketing
their products for treatments that aren't FDA-approved. Neurontin's
expressed use was as an anti-seizure drug for epileptics early on
and later for shingle-related nerve pain.
From 1994-2000, the Justice Department claims Warner-Lambert marketed
Neurontin illegally in a number of ways:
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Lied to doctors about the drug's effectiveness
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Paid doctors to allow a sales representative to sit in on sessions
with patients
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Paid doctors, some up to $250,000, to unethically talk up Neurontin
to other physicians
The list of diseases the company claimed Neurontin could cure was
so ridiculously long, some employees called it the "snake oil"
list. Nevertheless, Warner-Lambert's plan worked to perfection.
The government estimates off-label uses for Neurontin increased
from 40 to 94 percent from 1995-2002. Today, the estimated percentage
of off-label use stands at 90 percent. Some 12 million people have
taken Neurontin over the past decade and 60 countries have approved
it to treat pain.
Still, government prosecutors believed the actions of Warner-Lambert
forced Medicare to pay for an excessive number of prescriptions
the agency didn't need to fill. So much so that one official believes
directly increased
medical costs to consumer, states and insurers.
One U.S. attorney who prosecuted the Neurontin case hopes drug
industry practices will change due to the ruling, but doubts it
will have any effect on the drug's popularity. Why?
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Although physicians are required to notify insurance companies
and Medicaid for approval when they prescribe specific medications,
it's seldom done with Neurontin
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Congress voted to allow Medicaid to pay for FDA-approved drugs
or those supported by one of three medical directories whose
rulings are based on small studies that could be skewed
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Doctors want to help their patients by allowing them to try
drugs that might work, even those not approved by FDA
USA
Today August 17, 2004
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